Compliance with confidence

Welcome to Brandwood CKC, a trusted regulatory partner to the biomedical industries for more than 20 years. Our team's deep expertise, international network and proven strategic approach can help you successfully navigate the pathways to global market access.

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How we can help your business

Brandwood CKC offers a wide range of regulatory, technical and commercial services to partner your business and your product to success in Australia, New Zealand and the broader global markets of Asia-Pacific, North America and Europe.

Strategic Planning

Product Development and Standards

Regulatory Submissions

Re-scheduling / Re-classification Services

Postmarket Compliance & Surveillance

Regulatory and Administrative Appeals

Literature-Based Medicine Submissions

Biosimilar and Biotechnology Medicine Development

Due Diligence and Technical Assessment

Quality Management Systems

Authorised Representation, Sponsorship & Distributor Management

Reimbursement – Strategy, Advice and Submissions

Distributor Services

Events & Webinars

Join us on the world stage or online.

23 March

Asia Pacific Device Summit

The Nixon Library Yorba Linda, California

28 October

OC LIFe (Lifesciences Innovators Forum) – Impacts of COVID on Clinical Trial Pathways

Online

22 October

WEBINAR: Hitting the Accelerator! TGA’s Approaches to Speeding Up Medicine Approvals (Pre recorded)

Online

MORE EVENTS & WEBINARS

Make your next step the right step

Let us show you how our proven strategic approach can open your global markets.

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Biomedical Industry Updates

Biomedical news, views, insights and case studies from across the globe.

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

By Luis Jimenez | 19 October 2020

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their...

TGA will require DOC’s to be submitted for Class I ARTG registrations

By Luis Jimenez | 2 October 2020

Australia’s, Therapeutic Goods Administration (TGA) issued a notice on 1 October 2020, in addition to an email to stakeholders prior, specifying new policies for the...

Your guide to claiming temporary exemption from TGO91/92 compliance

By Nicole Tan | 2 October 2020

As described in the article, Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19, 31 August 2020 marked the end of the medicines packaging reform...

Video Gallery

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Let Us Know What You Think

If you've got any questions or would just like to learn more about what how we could work together, then get in touch.

LEARN MORE

Compliance with confidence

How we can help your business

Events & Webinars

Asia Pacific Device Summit

OC LIFe (Lifesciences Innovators Forum) – Impacts of COVID on Clinical Trial Pathways

WEBINAR: Hitting the Accelerator! TGA’s Approaches to Speeding Up Medicine Approvals (Pre recorded)

Make your next step the right step

Biomedical Industry Updates

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

TGA will require DOC’s to be submitted for Class I ARTG registrations

Your guide to claiming temporary exemption from TGO91/92 compliance

Video Gallery

Hitting the Accelerator! TGA’s Approaches to Speeding Up Medicine Approvals

Medical Device Regulations Under COVID – What You Need To Know

Blood, Sweat and Tears: An Update to In Vitro Diagnostics Regulatory Requirements Worldwide

Medical Device Software: Current Developments in the Regulatory World

Let Us Know What You Think

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